MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 4 FR X 13 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number CS-14402

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 06/01/2015

Event Type  Injury  

Event Description

It was reported that the md attempted to insert the catheter into the pt at 14:00.However, during procedure, the tip of guide wire became curved, so the user cut off the j-shaped part of guide wire and inserted it into the pt's right femoral vein.After insertion of the catheter, the md tried to confirm the location of placement of the catheter under radiographic guidance and found that the guide wire remained inside the pt's body from right atrium to inferior vena cava.At approximately 16:00 in the operating room, the md removed the residual material via internal jugular vein by use of a snare.The catheter was not removed and instead continued to be used, and the pt was reported in stable condition for now.This issue caused the therapy to be delayed by 1 hr, however, there were no additional complications due ot this occurrence.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint was confirmed through evaluation of a returned product sample.The customer provided a guide wire that was separated into two pieces.The catheter was not returned.Guide wire piece a was the shorter of the two pieces and had a 90 degree angle kink near one end.Piece b had two bends.Both pieces consisted of only the coil wire and were partly unraveled.Microscopic examination revealed the coil wire ends had two flat slanted sides coming to a point, indicative of a cut with a scissors or similar tool.Opposed to a blunt or jagged edge if broken.No welds or core wire were returned.Due to the condition of the sample, the dimensions could not be confirmed.A review of manufacturing records did not yield any relevant findings.The customer reported cutting the wire to remove the j-bend after the wire curved.This is in direct conflict with the instructions which state "do not cut the guide wire." based on the information reported and the condition of the sample returned, use error appears to have caused or contributed to this event.A customer in-service was initiated for this complaint.

• Brand Name: CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: ADULT MULTI LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 01; EZ 591 01
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4826454
• MDR Text Key: 17934033
• Report Number: 3006425876-2015-00189
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F14H0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 06/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 17